New Treatments for Troublesome Bleeding in Implanon Users
Menstrual Problem
About this trial
This is an interventional treatment trial for Menstrual Problem focused on measuring Implanon users, Frequent bleeding, Prolonged bleeding, Comparison of treatments, Placebo controlled, Randomly allocated tretment
Eligibility Criteria
Inclusion Criteria:
- Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual diary for 6 months
Exclusion Criteria:
Women who have currently or previously had
- Heart attack or stroke
- Blood clot in a vein
- High blood pressure
- Severe liver or kidney disease
- Blood pressure > 135 mm systolic or >85 mm diastolic
- Migraine with aura
- Breast cancer or any genital cancer
- Severe chronic liver or kidney disease
- Women with known sensitivity to ethinyl oestradiol, progestogens
- Women taking phenytoin, carbamazepine or phenobarbitol
- Women who are pregnant
- Women who are lactating
- Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria
Sites / Locations
- Sydney centre for Reproductive Health Research, FPNSW
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Group 1 Marvelon ,placebo
Marvelon
NuvaRing
Starch capsule
7 days daily intake of oral capsule containing "Marvelon" ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules containing starch for 21 day treatment Cycle
21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms for one cycle of 21 days
21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days Treatment will be for 21 days
21 days daily oral placebo capsules Treatment will be for one 21 day cycle